Cleared Special

K073162 - SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING

K073162 is an FDA 510(k) clearance for SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUS..., manufactured by Kensey Nash Corporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 91-day FDA review.

K073162 · Kensey Nash Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
91d
Days
Class 2
Risk

K073162 is an FDA 510(k) clearance for the SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) .... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Kensey Nash Corporation (Exton, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K073162

510(k) Number K073162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2007
Decision Date February 08, 2008
Days to Decision 91 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 742
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K073162.
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
K072460 · Abbott Vascular, Inc. · Apr 2008
RUNTHROUGH NS EXTENSION WIRE
K080563 · Terumo Medical Corp. · Mar 2008
MANDREL GUIDEWIRES OR M-WIRES
K080144 · Lake Region Mfg., Inc. · Feb 2008
PEGASUS STEERABLE (PTCA) GUIDEWIRE
K073655 · Lake Region Mfg., Inc. · Jan 2008
ASAHI PTCA GUIDE WIRE
K070945 · Asahi Intecc Co., Ltd. · Jan 2008
CPS COURIER GUIDEWIRE
K073082 · Brivant, Ltd. · Jan 2008
K073162 · SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING
Download PDF FDA Summary Kensey Nash Corporati…